BEUDAMED
    FDA Enforcement Class II Ongoing

    IntelePACS - InteleConnect / TechPortal

    Recall: Z-0723-2026 · Reported December 3, 2025

    Enforcement

    Recall Number
    Z-0723-2026
    Event ID
    97868
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    INTELERAD MEDICAL SYSTEMS INCORPORATED
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 3, 2025
    Initiation Date
    October 17, 2025
    Classification Date
    November 26, 2025
    Address
    800, Boul. de Maisonneuve Est, 12th floor, Montreal, N/A, N/A, Canada

    Description

    IntelePACS - InteleConnect / TechPortal

    Reason

    Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

    Code Info

    UDI-DI: B228INTELEPACS0. Version/Dates of Distribution: PACS-5-6-1-R64 through R68/02 Jul 2025 - 10 Sep 2025, PACS-5-7-1-R42 through R47/26 June 2025 - 25 Sep 2025, PACS 5-8-1-R20 through R23/26 Jun 2025 - 25 Sep 2025, PACS-5-9-1-R1 through R3/30 Jun 2025 - 09 Sep 2025

    Distribution

    US Nationwide distribution in the states of AZ, CT, AL, IL, WA, MD, NJ,CA, TN, IN, FL, NC.

    Quantity

    19